by Regulatory & More Nov 12, 2020

Trend Reporting under the MDR and IVDR (Art. 88/83)

Trend Reporting: Definition & Purpose

A trend can be defined as a graphical representation of a variable’s tendency, over time, to increase, decrease or remain unchanged. Usually a trend is represented in a trend control chart, who represents the deviation from an expected trend and it is used to evaluate the stability of a process (American Society for Quality, ASQ)

In the MDR and IVDR context, the purpose is to monitor the number of incidents not classified as serious incidents, over time, via EUDAMED, in order to determine if the benefit-risk analysis of the device has changed.

MDR/IVDR Requirements about Trend Reporting

Article 88 MDR and article 83 IVDR mention the requirements for the trend reporting. Both articles have different requirements for medical devices and IVDs. (See Comparison Table below).

About devices falling under the MDR

Manufacturers shall report any statistically significant increase in the frequency or severity of incidents that are:

not serious incidents, or
incident that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis, and which have led or may led to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits.

The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.

The manufacturer shall also specify how to manage these incidents and provide the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance (PMS) plan.

About devices falling under the IVDR

Manufacturers shall report any statistically significant increase in the frequency or severity of incidents that are:

not serious incidents, or
incidents which have led or may led to risks to the health or safety of patients, users or other person or of any significant increase in expected erroneous results established in comparison to the stated performance of the device.

The significant increase in expected erroneous results shall be established in comparison to the stated performance of the device as specified in the technical documentation and product information.

The manufacturer shall also specify how to manage these events and provide the methodology used for determining any statistically significant increase in the frequency or severity of such events or change in performance, as well as the observation period, in the post-market surveillance (PMS) plan.

About Competent Authortites

Competent authorities may assess these data and require the manufacturer to take action. In that case, the competent authority shall inform the Europeaan Commisison, the other competenet authortires and the notified body that issuedcthe certificate of the results of such assessment and of the adoption of such measures.

Comparison Table

Differences are in orange.

EU MDR – Regulation (EU) 2017/745

EU IVDR – Regulation (EU) 2017/746

Article 88

Trend reporting

Article 83

Trend reporting

1. Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 8 of Annex I and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.

1. Manufacturers shall report by means of the electronic system referred to in Article 87 any statistically significant increase in the frequency or severity of incidents that are not serious incidents that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 8 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons or of any significant increase in expected erroneous results established in comparison to the stated performance of the device as referred to in points (a) and (b) of Section 9.1 of Annex I and specified in the technical documentation and product information.

The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance plan referred to in Article 84.

The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such events or change in performance, as well as the observation period, in the post-market surveillance plan referred to in Article 79.

2. The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1 and require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. Each competent authority shall inform the Commission, the other competent authorities and the notified body that issued the certificate, of the results of such assessment and of the adoption of such measures.

References

Regulation (EU) 2017/745 MDR: 02017R0745 — EN — 24.04.2020 — 001.001 (consolidated version)

Regulation (EU) 2017/746 IVDR: 02017R0746 — EN — 05.05.2017 — 000.003 (consolidated version)

In Vitro Diagnostics IVD IVDR MD MDR Medical Devices Trend Reporting